Lifestyle Integrated Functional Exercise for People With Dementia: a Home-based Physical Activity Program

NCT03757806 | Completed

• 1 other identifier: SFRH/BD/120695/2016
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity improves cognitive function and the ability to perform activities of daily living in people with dementia and reduces caregivers' burden thus, enhancing quality of life of people with dementia and their caregivers. The wish of most people with dementia, and their caregivers, is to live at their home, for as long as possible. However community-dwelling people with dementia have low levels of physical activity, increasing dependency, which often leads to institutionalization. The Lifestyle Integrated Functional Exercise (LiFE) program has been shown to decrease sedentary activity time and dependency in activities of daily living of older people, however, it has never been implemented in people with dementia. LiFE might be promising as it focuses on establishing new behaviors within selected contexts to stimulate physical activity at home. Therefore, a home-based physical activity program, based on LiFE and involving caregivers, LiFE4D, will be implemented and evaluated in community-dwelling people with dementia.

Conditions

Dementia

Keywords

Dementia; Physical activity; Home-based; Lifestyle

Outcome Measures

Primary Outcomes (1)

• 2 Minute Step test - change in exercise tolerance

  Participants' exercise tolerance will be assessed with the 2 Minute Step Test, counting the number of times the right knee is raised to the level of the mark on the wall or board (half way between the participant's knee and iliac crest). Higher number of repetitions indicate better performance.

  Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.

Secondary Outcomes (16)

• Addenbrooke's Cognitive Examination III - change in cognitive function

  Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.

• Brief Balance Evaluation System Test - change in balance

  Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.

• Brief Physical Activity Assessment tool - change in self-reported physical activity

  Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.

• Accelerometer-based activity monitors - change in physical activity levels

  Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.

• Handgrip Dynamometer - change in maximum isometric strength of the hand and forearm muscles

  Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive the LiFE4D in addition to usual care (e.g., pharmacologic treatment).

Other: Experimental group

Control group

NO INTERVENTION

The control group will receive usual care only.

Interventions

Experimental group OTHER

LiFE4D is an individualised programme, adapted to the participant's needs/preferences. People with Dementia will receive assistance to increase their physical activity multiple times/day in their everyday tasks with the support/supervision of their caregivers. The programme last for 12 weeks, with a lower face tracking over time with the health professional but replaced by caregivers. The intervention includes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt physical activity to everyday tasks, increase tasks frequency and intensity, monitor progress, clarify doubts, motivate and manage expectations. Phone calls aim to monitor motivation/evolution and clarify doubts.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a diagnosis of mild/moderate dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V); are living at home; are not participating in exercise training; are able to follow instructions and have a caregiver.

You may not qualify if:

• have been hospitalized in the previous month; present any clinical condition that precludes them to be involved in physical activity; have been taking medication that affect exercise capacity/bone density.

Sponsors & Collaborators

• Aveiro University: lead
• School of Health, Polytechnic Institute of Setúbal (ESS/IPS): collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

Location

MeSH Terms

Conditions

Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Alda S Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer, Dr.

Model Details: A randomized controlled trial will be conducted. Participants will be randomized to the control group or intervention group. The control group will receive usual care only (e.g., pharmacologic treatment), whilst the experimental group will receive an individualized home-based physical activity program at home (LiFE4D) in addition to usual care.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: December 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: May 1, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)